Subject: Notified Draft Amendment Rules For The Registration Of Class A Medical Devices (CDSCO New Rules)
The Ministry of Health and Family Welfare on Tuesday notified draft amendment rules for the registration of Class A medical devices through an identified online portal established for the purpose.
All the A and B-class manufacturers are required to transition to the licensing regime by 1st October. This notification came as a big relief to the manufacturers who are still awaiting audits from the government licensing authorities.
The Key highlights of the draft amendment rules for Manufacturer
- The manufacturer has to only submit an undertaking stating that the proposed device is Class A Medical Device (non-sterile and/or non-measuring)
- The manufacturer shall self-certify that the product is conforming to the essential principles’ checklist of safety and performance of such devices.
- The manufacturer shall self-certify to comply with the standards prescribed in the Medical Devices Rules, 2017.
To encourage the ease of doing business in India, on 15th July 2022 the Department of Consumer Affairs vide the Legal Metrology (Packaged Commodities), (Second Amendment) Rules 2022 has allowed the electronics manufacturers, packers and importers to declare certain mandatory declarations through the QR Code for a period of 1 Year if the same are not declared on the package itself.
(i): All the goods companies and producers of electronic goods have to ensure that at atleast of 60% of their produced electronic waste is collected and further recycled by the year 2023 with targets to further increase them to 70% and 80% in the year 2024 and 2025 respectively.
(ii): Now the PIBO (Producer, Importers and brand owners) have to register themselves on online portal with Central pollution control board and have to specify their annual production and e-waste collection targets.
(iii): In case the company fails to meet the annual targets as specified in the draft, then the company is liable to pay fine or an environmental compensation to the central pollution control board. However, the draft does not confirms the quantum of the said fines.
(iv): Even after three years, companies that fall short of their goals can meet a year's goal. Those who accomplish their targets with a year's delay will be repaid 85 percent of their fine after two years, 60 percent after the second year, and 30 percent after the third year.
(v): The EPR also mandates that makers establish e-waste exchange facilities to assist collection and recycling, as well as assigning explicit responsibility for safe disposal to bulk consumers of electronic devices.
(vi): The notification covers a wide range of electronic devices, including computers, landline and mobile phones, cameras, recorders, music systems, microwaves, refrigerators, photovoltaic cells and medical equipment.
(vii): The EPR also mandates that makers establish e-waste exchange facilities to assist collection and recycling, as well as assigning explicit responsibility for safe disposal to bulk consumers of electronic devices. The responsibility for earmarking industrial space for e-waste dismantling and recycling facilities, undertaking industrial skill development, and establishing measures to protect the health and safety of workers engaged in e-waste dismantling and recycling facilities has been entrusted to the state governments.
On 28 April 2022, the Bureau of Indian Standard published an update regarding the Surveillance to be conducted on all stakeholders registered with BIS
- According to the updated guidelines of market surveillance (BIS), the cost of samples and the testing fee of the sample drawn for surveillance shall be paid by the licensee.
- The charges associated with surveillance shall be collected in advance (interest fee) from the licensee so that the implementation process of Surveillance can be more effective and hassle-free.
- The surveillance cost for the product will be retained by BIS and refunded only at the time of expiry/cancellation of the license.
- Actual invoices will be raised to the licensee/Authorized Indian Representative upon completion of procurement, packaging/transportation, and submission of samples to BIS/BIS recognized labs, against which payment will be made by the manufacturer/Authorized Indian Representative to replenish the cost incurred by BIS along with applicable taxes.
- The cost of surveillance is subject to periodic adjustment by BIS. All licensees must comply with the revised surveillance charges if they are revised.
- BIS is authorized to draw the samples from the open market. But for the foreign Manufactures, their Indian representative has to submit all the details of their distribution channel(s) including warehouses, wholesalers, retailers, etc.
- Once the test reports are obtained and deemed to be non-conforming to the applicable Standard(s), BIS will notify the licensee/Authorized Indian Representative, and steps will be taken in accordance with the procedures for dealing with surveillance samples' non-conformity(s).
- Once the surveillance procedure is completed and the test report is passed, the Licensee/Authorized Indian Representative will be notified via the portal to collect the sample from the concerned laboratory where the sample was sent for testing.
- Only once the surveillance process is completed will the licensee/Authorized Indian Representative be given information about the testing lab. If the licensee/Authorized Indian Representative fails to collect the samples, laboratories can dispose of them according to the BIS's Laboratory Recognition Scheme (LRS) disposal policy.
In the recent update from BIS received on 17th March 2022, the amendment against the old regulation of Conformity Assessment 2018 was issued.
The Conformity Assessment Amendment Regulation 2022 includes the introduction of a new scheme that is BIS Scheme X. The main highlights of the issued amendment are
- The Bureau may grant a certificate of conformity instead of a licence in case the product is not desired to be manufactured on a continuous basis and in such a case, the manufacturer shall not be authorised to use the Standard Mark.
- The manufacturer may opt for a demonstration of conformity of the management system to the specified requirements given in standard
- Each product or the package or both shall be marked with the Standard Mark in case of licence
- The licence shall be granted initially for not less than three years and up to six years
The GOI of India on 13th April released an official notification stating that the customs duty on the import of cotton will be removed till 30th September 2022.
This will not only help boost our manufacturing and exports but also bring down prices benefiting consumers.
[TO BE PUBLISHED IN GAZETTE OF INDIA, EXTRAORDINARY, PART ||, SECTION 3, SUB-SECTION (1)]
GOVERNMENT OF INDIA
MINISTRY OF FINANCE
(DEPARTMENT OF REVENUE)
New Delhi, the 13th of April 2022
G.S.R. (E). In exercise of the powers conferred by sub-section (1) of section 25 of the customs Act, 1962 (52 of 1962) and section 124 of the finance Act, 2021 (13 of 2021) (hereinafter referred to as the said section), the Central Government, on being satisfied that it is necessary in the public interest so to do, hereby exempts goods of the description specified in column (3) of the Table below and falling within the Chapter, heading, sub-heading or tariff item of the First Schedule to the Customs Tariff Act, 1975, (51 of 1975) as specified in column (2) of the said Table, when imported into India, from so Much of the duty of customs leviable thereon under the First Schedule to the Customs Tariff Act, 1975 (51 of 1975), as is in excess of the amount calculated at the standard rate specified in the corresponding entry in column (4) of the said Table and from so much of the Agriculture Infrastructure and Development Cass (hereinafter referred to as AIDC) leviable thereon Under the said section, as is in excess of the amount calculated at the rate specified in column (5) of the said Table, namely:-
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